A Phase 2 interventional study of Saline Solution (NaCl 0,9%) and Triamcinolone Acetonide in Trapeziometacarpal Osteoarthritis, sponsored by Université du Québec à Trois-Rivières. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Université du Québec à Trois-Rivières · Phase 2, Interventional, and Treatment
Thumb osteoarthritis or trapeziometacarpal osteoarthritis (TMO) is a common and painful form of hand arthritis that limits thumb mobility and hand function, affecting patients' quality of life. Although corticosteroids injections are a typical treatment, their effectiveness has been challenged, and side effects have been reported. Recent studies suggest that saline injections, usually considered inactive, might be a viable treatment option. The primary goal of this study is to compare the effectiveness of saline injections versus corticosteroids injections in reducing TMO-related pain and improving hand function. In this study, 40 people with TMO will be randomly assigned to receive either a corticosteroids or a saline injection, without them or the doctors performing the injection knowing which one was administered (double blind). If saline injections prove more effective, they could provide a less harmful and cheaper therapeutic alternative for TMO patients.
Trapeziometacarpal osteoarthritis (TMO) is one of the most painful, disabling and prevalent hand osteoarthritis. One of the most common treatments for TMO is an intra-articular corticosteroids injection. However, non-superiority of corticosteroids injection over placebo to reduce pain has also been reported for TMO and other types of osteoarthritis (knee, hip, or shoulder). Furthermore, adverse effects of corticosteroids injection such as subcutaneous atrophy, tendon ruptures, and articular cartilage damage have been reported. Given the uncertain relevance of corticosteroids injection as a therapeutic agent, it becomes imperative to consider alternative options. In fact, three systematic reviews suggest that saline injections may be a viable option for TMO or knee pain.
To investigate the hypothesis that saline injection is a more effective modality than corticosteroids injection for the treatment of TMO in terms of reducing TMO pain and improving hand function, we must undertake a large, randomized trial in real clinical settings to ensure the acquisition of high-quality evidence. This pilot project is a preparatory phase for a larger study aimed at comparing the effectiveness of saline and corticosteroids injections in treating TMO, focusing on pain reduction and functional improvements. The study design is a pragmatic, double-blind randomized trial, adhering to PRECIS-2 guidelines.
The pilot randomized controlled trial will assess the feasibility of a study by evaluating aspects such as recruitment capabilities, retention, and the success of blinding techniques for participants and clinicians. It will also identify potential challenges and gather preliminary data to support a funding application for the full-scale study. Recruitment and data collection are planned over a 12-month period, targeting 40 participants initially to refine procedures and validate the study's feasibility. Participants will be randomly assigned to treatment, and the clinicians delivering the intervention will be blinded to the content of the injections. The study's primary outcome will measure pain intensity using a numeric scale at multiple time points, while secondary outcomes include upper limb functional limitations using the QuickDASH scale. These will be measured at baseline, before treatment, and at follow-up, 1, 3, and 6 months after treatment.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Université du Québec à Trois-Rivières is the lead sponsor of 40 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single injection of saline solution
Drug: Saline Solution (NaCl 0,9%)
Usual care, consisting on a single injection of corticosteroids
Drug: Triamcinolone Acetonide
Ultrasound/fluoroscopy-guided intra-articular injection of 0.25ml of 0.9% saline solution.
Also known as: Saline solution
Ultrasound-guided intra-articular injection 0.25ml (10 mg) of triamcinolone.
Also known as: Corticosteroid
Rate of participant recruitment
The number of participants recruited per week, raw and divided by those screened for eligibility and those deemed eligible
Time frame: Through study completion (estimated time, 1 year)
Rate of participants completing the follow-ups
The number of participants completing the follow-ups at 1, 3, and 6 months, divided by those recruited
Time frame: Through study completion (estimated time, 1 year)
Success of blinded procedures for clinicians
Success of blinded procedures for physicians will be by asking them by email after the injection to guess which treatment they administered. Three response categories for treatment guess: 'corticosteroid injection', 'saline injection', or 'I don't know'.
Time frame: Up to 24 hours after each injection
Success of blinded procedures for patients
Success of blinded procedures for patients will be investigated by asking them to guess which treatment they will have received via the post-injection questionnaire. Three response categories for treatment guess are 'corticosteroid injection', 'saline injection', or 'I don't know', after the last follow-up).
Time frame: 1, 3, and 6 months after receiving the injection
Trapeziometacarpal pain intensity
Three types of pain intensity (current, on the average in the last 7 days, at its worst in the last 7 days) will be measured using a 0-10 rating scale (0 = no pain and 10 = worst pain possible)
Time frame: Baseline, 1, 3, and 6 months after injection
QuickDASH questionnaire (short version of the 30-item Disabilities of the Arm, Shoulder and Hand).
11-item questionnaire assesses the level of physical function and symptoms among patients with upper limb musculoskeletal condition. The total score ranges from 0 to 100 and the higher it is, the more disabled is the patient.
Time frame: Baseline, 1, 3, and 6 months after injection
Concomitant analgesic use
This will be captured using the Cumulative Analgesic Consumption Score (CACS), a tool that combines a qualitative assessment based on the World Health Organization analgesic ladder with a quantitative evaluation based on a score computed from the number of analgesics taken from each of three different categories: acetaminophen/NSAIDs, weak opioids, and strong opioids.
Time frame: Baseline, 1, 3, and 6 months after injection
Adverse events
Side effects will be reported systematically by using a questionnaire with 5 items assessing the presence, type, frequency, severity and duration of injection-related adverse events.
Time frame: 24 hours after the injection and at 1-month, 3-month- and 6-month post-injection.
Second injection
The number of participants requesting a second injection with a different solution due to a perceived lack of efficacy, as well as the number of participants requesting a second injection with the same solution due to pain relapse will be compared between groups will be compared between groups (saline vs. cortisone)
Time frame: 1, 3, and 6 months after injection
Arthroplasty
The number of participants undergoing arthroplasty during the study period will also be compared between groups..
Time frame: 1, 3, and 6 months after injection
Plan to share: Yes — IPD will be shared by the investigators upon reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Undecided yet
Access criteria: IPD will be shared by the investigators upon reasonable request
Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.
Of 82 phase 2 interventional studies under Osteoarthritis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 25 months is above that.
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Studies of the drug tested here: Saline Solution
Université du Québec à Trois-Rivières